MAUDE Adverse Event Report: ROCHE DIAGNOSTICS TG G2 ELECSYS; THYROGLOBULIN TEST SYSTEM

Catalog Number	08906556160
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/07/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The analyzer serial number is (b)(6).The investigation is ongoing.
Event or Problem Description
There was an allegation of questionable roche diagnostics elecsys tg ii results for 1 patient sample on a cobas 6000 e601 module.The initial tg result was 1.28 ng/ml.The sample was repeated and the result was >500 ng/ml.A 1:10 dilution was made of the sample and repeated and the result was 954.3 ng/ml.No questionable results were reported outside of the laboratory.
Additional Manufacturer Narrative
The calibration and qc recovery data provided was acceptable.Based on the calibration and qc data, a general reagent issue could be excluded.The root cause of the event was found to be consistent with pre-analytical sample handling issues.

• Brand Name: TG G2 ELECSYS
• Common Device Name: THYROGLOBULIN TEST SYSTEM
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• Manufacturer (Section G): ROCHE DIAGNOSTICS GMBH; sandhofer strasse 116; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: amy nelson ; 9115 hague road; indianapolis, IN 46250
• MDR Report Key: 19576636
• Report Number: 1823260-2024-01820
• Device Sequence Number: 20955748
• Product Code: MSW
• UDI-Device Identifier: 07613336203569
• UDI-Public: 07613336203569
• Combination Product (Y/N): Y
• Initial Reporter Country: ID
• PMA/510(K) Number: K221890
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 08906556160
• Device Lot Number: 769273
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/27/2024
• Supplement Date Received by Manufacturer: 07/08/2024
• Initial Report FDA Received Date: 06/20/2024
• Supplement Report FDA Received Date: 07/29/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown